阿司匹林与氯吡格雷关联使用与华法林治疗发生出血的比较研究

中国临床药理学与治疗学 ›› 2013, Vol. 18 ›› Issue (11): 1251-1259.

阿司匹林与氯吡格雷关联使用与华法林治疗发生出血的比较研究

贠文博¹, 蒋朋利¹, 吴晶¹, 孙鹤^1,2

¹天津大学药物科学与技术学院,天津 300072;
²天士力集团,天津 300410

收稿日期:2012-11-16 修回日期:2013-10-23 出版日期:2013-11-26 发布日期:2013-11-22
通讯作者: 孙鹤,男,博士,教授,博士生导师,研究方向:药政管理与临床药理。Tel: 022-27892883 E-mail: henrysunusa@gmail.com;吴晶,女,博士,副教授,硕士生导师,研究方向:药物经济学。Tel: 022-27892883 E-mail: daisyjw@gmail.com
作者简介:贠文博,女,硕士研究生,研究方向:药事管理。Tel: 022-27892883 E-mail: runwenbo602@gmail.com

Bleeding risk is higher when warfarin used alone compared to the associated use of aspirin with clopidogrel

YUN Wen-bo¹, JIANG Peng-li¹, WU Jing¹, SUN He^1,2

¹School of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072, China;
²Tasly R& D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300410,China

Received:2012-11-16 Revised:2013-10-23 Online:2013-11-26 Published:2013-11-22

摘要/Abstract

摘要： 目的: 基于FDA自发呈报系统/不良反应报告系统数据库评价阿司匹林与氯吡格雷关联使用同华法林治疗发生出血不良反应的差异。方法: 去掉重复报告后,依据用药情况,把不良反应报告分为阿司匹林/氯吡格雷组,华法林治疗组和对照组,依据《国际医学用语辞典》定义出血有关的不良反应。采用描述性统计、Logistic回归模型和不良反应风险比分析阿司匹林/氯吡格雷用药与华法林用药情况下患者发生出血情况之间的差异。结果: 阿司匹林与氯吡格雷关联使用的出血率为 20.80%,发生率最高的为胃肠系统出血(8.23%),华法林治疗的出血率为 22.30%,发生率最高的为胃肠系统出血(7.81%)。两种治疗发生的神经系统出血差异无统计学意义(P>0.05)。两种用药情况下患者出血率随着年龄段的升高而升高。结论: 依据FDA不良反应数据库分析得出,华法林治疗导致的出血率(22.30%)高于阿司匹林与氯吡格雷关联使用(20.80%)(P<0.05),且两种用药情况下,患者发生的出血类型存在一定差异。

关键词: 阿司匹林, 氯吡格雷, 华法林, 不良反应, 药物警戒

Abstract: AIM: To compare the risk of bleeding complication due to the associated use of aspirin with clopidogrel compared to those warfarin used alone based on FDA Spontaneous Reporting System and Adverse Events Reporting System (SRS/AERS) database.METHODS: After excluding duplicated records, reports were divided into three index groups i.e. associated use of aspirin with clopidogrel group, warfarin group and reference group,and define haemorrhages-related adverse events (HRAEs) according to Medical Dictionary for Regulatory Activities. Descriptive statistics, logistic regression and odds ratios were used to estimate the risk and difference of bleeding complications for these three scenarios.RESULTS: frequency of HRAE connected with the associated aspirin/clopidogrel use was 20.80%, and gastrointestinal system HRAEs were the most frequently reported bleeding event (8.23%). The frequency of HRAE connected with the warfarin used alone was 22.30%, and gastrointestinal system HRAEs were the most frequently reported bleeding event (7.81%). The frequency of nervous system HRAEs for different groups has no significant difference (P>0.05). The frequency of HRAEs increased as age increases for both groups.CONCLUSION: The risk of HRAEs with warfarin used alone (20.80%) is higher than the associated aspirin/clopidogrel use (22.30%) in the clinical use based on FDA SRS/AERS (P<0.05). The types of bleeding complications are not similar for both situation.

Key words: Aspirin, Clopidogrel, Warfarin, Adverse event, Pharmacovigilance

中图分类号:

R442.7

贠文博, 蒋朋利, 吴晶, 孙鹤. 阿司匹林与氯吡格雷关联使用与华法林治疗发生出血的比较研究[J]. 中国临床药理学与治疗学, 2013, 18(11): 1251-1259.

YUN Wen-bo¹, JIANG Peng-li¹, WU Jing¹, SUN He^1,2. Bleeding risk is higher when warfarin used alone compared to the associated use of aspirin with clopidogrel[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(11): 1251-1259.

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